FDA 510(k) Application Details - K221834

Device Classification Name	More FDA Info for this Device
510(K) Number	K221834
Device Name	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Applicant	Centers For Disease Control And Prevention 1600 Clifton Rd, NE MS H24-11 ATLANTA, GA 30329 US Other 510(k) Applications for this Company
Contact	Julie Villanueva, PhD Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2022
Decision Date	06/24/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review